Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)

Brief Summary:
This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy regimens for metastatic disease.

Detailed Description:
Approximately 400 eligible subjects will be randomized to one of the following 2 treatment arms:
- Investigational Arm: Sacituzumab Govitecan 10 mg/kg via IV injection administered on Day 1 and Day 8 (21-day cycle).
- Control Arm: Recommended doses and schedules as per NCCN guidelines (with dose modifications if too toxic).
Eribulin; Capecitabine; Gemcitabine; Vinorelbine


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Sacituzumab Govitecan vs Physician's Choice in Subjects With Hormonal Receptor-Positive Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Who Have Failed at Least 2 Prior Chemotherapy Regimens
Actual Study Start Date: May 30, 2019
Estimated Primary Completion Date: November 2021
Estimated Study Completion Date: May 2023

Arms:
- Experimental: Sacituzumab Govitecan
- Active Comparator: TPC Comparator